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Recruiting NCT06025253

PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Trial Parameters

Condition Wound Surgical
Sponsor Royal College of Surgeons, Ireland
Study Type INTERVENTIONAL
Phase N/A
Enrollment 728
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-03-01
Completion 2026-03-01
Interventions
Negative Pressure Wound TherapyStandard Wound Dressing

Brief Summary

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.

Eligibility Criteria

Inclusion Criteria: * Patients aged 18 years or older; * Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication; * Patients with primary closure of the surgical incision using either interrupted or continuous sutures Exclusion Criteria: * Patients \<18 years; * Women who are pregnant and/or breast-feeding; * Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump; * Patients with amputations where skin glue is the only means of skin closure * Patients with a clinically absent femoral pulse

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